RECRUITING

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Description

The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.

Study Overview

Study Details

Study overview

The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Condition
Bladder Carcinoma
Intervention / Treatment

-

Contacts and Locations

Redwood City

Redwood City, Redwood City, California, United States, 94063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age \> 18 years old AND
  • * Were treated with curative intent AND
  • * Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND
  • * Provided written informed consent to participate in the study AND
  • * Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND
  • * Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent AND
  • * Have at least one blood sample collected 4-12 weeks after completion of primary treatment of the Index Cancer
  • * Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:
  • * Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),
  • * Cohort 2: Non-small cell lung cancer (stage II-III),
  • * Cohort 3: Invasive breast carcinoma with all of the following:
  • * Cohort 4: Stage IIb-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent,
  • * Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III),
  • * Cohort 6: Gastric adenocarcinoma (stage II-III),
  • * Cohort 7: Surgically resected pancreatic adenocarcinoma,
  • * Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-III oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, paranasal sinus, and salivary gland cancers),
  • * Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as stage IC-III or stage I that has high grade (grade 3-4) or clear cell histology),
  • * Cohort 10: High-risk endometrial carcinoma (defined as having any of the following: serous or clear cell adenocarcinoma histology (any stage), grade 3 or 4 deeply invasive (T1b or greater) endometrioid carcinoma, stage III disease (any histology)),
  • * Cohort 11: High-risk renal cell carcinoma (defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent)
  • * History of allogeneic organ or tissue transplant
  • * Index cancer has neuroendocrine histology
  • * History of another primary cancer, with the exception of the following (if adequately treated and the patient is without evidence of disease at the time of enrollment): in situ cancers, non-melanoma skin carcinoma, localized low-risk prostate cancer (Gleason score \< 6) with PSA in the normal range, and stage I papillary thyroid carcinoma.
  • * Known distant metastasis at time of enrollment (with the exception of participants with limited/resectable stage IV cutaneous melanoma or RCC)
  • * Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test in the post-treatment surveillance setting at predicting/detecting recurrence

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Guardant Health, Inc.,

Study Director, STUDY_DIRECTOR, Guardant Health, Inc.

Study Record Dates

2028-02